Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202004791781363 Date of Approval: 16/04/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effects of scheduled physical activity on depressive symptoms among in-school adolescents in Ondo State, Nigeria.
Official scientific title Effects of scheduled physical activity on depressive symptoms among in-school adolescents in Ondo State, Nigeria.
Brief summary describing the background and objectives of the trial According to the World Health Organization (WHO) report, at least one mental health disorder affects one in every four Nigerians. When compared with other African countries, Nigeria has the highest number of depression cases with a tank of 15th on suicide rates across the globe. There is an upward surge of various mental health issues among adolescents. The adolescent stage with it's uniqueness as a period of rapid change and development of an individual, factored against the challenge of weak parenting styles tend to be some of the reasons for the spike being experienced among this population. This is worsened by the cute shortage of resources in the form of personnel, infrastructure, funds, facility, etc for individuals suffering from mental health disorders. These and some other factors make it imperative device reliable, affordable and accessible options that can be adjuncts to existing empirical treatment/ management options. The objectives of this trial are as follows: 1. To assess the prevalence of depressive symptoms among in-school adolescents in Akure-South Local Government, Ondo State. 2. To explore factors that influence adolescents' participation in physical activities. 3. To determine the effects of scheduled physical activities as a behavioral therapy for depressive symptoms among in-school adolescents. 4. To compare depressive symptoms between males and females in the intervention group pre and post intervention. 5. To explore if there will be a significant level of satisfaction in the intervention programme among the intervention group post intervention.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 10/02/2020
Actual trial start date 24/02/2020
Anticipated date of last follow up 20/03/2020
Actual Last follow-up date 03/04/2020
Anticipated target sample size (number of participants) 20
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Physical activity Hourly for 3 days in a week 6 weeks The intervention started with the researcher psycho- educating the intervention group on depression, it's risk factors, course, implications and various empirical modes of managing it. This was done to improve their knowledge on depression, promote their compliance during the intervention programme and subsequently indoctrinate considerable bout of physical activity into their daily routine, outside their regular daily schedules. In line with WHO's Global recommendation on physical activity for health and Busch et al (2016), the sessions involve flexible and enjoyable exercises like jumping jacks, stationary mountain climbing, head-shoulders-Knees- Toes and various stretching activities which will be done to selected paces of music; initially slow paced music's which will be increased gradually as the programme progresses. The time of intervention is 7- 8' o clock in the morning before the commencement of school work while the site of the programme is an enclosed unoccupied classroom within the school compound. Each session has been broken down into the warm-up, main activity and cook-off sessions in order to prevent injury to the participants while also taking ensuring the availability of drinkable water in order to avoid dehydration in the course of the programme. 20
Control Group Wait list control group Nill The course of the program Nill 20 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Students between 12 and 17 years in the selected classes; Junior secondary 3 to Senior secondary 2 classes. Those who provide consent and also assents to take part in the study. Students who scored above 1 standard deviation from the mean score for the Short mood and feelings questionnaire (SMFQ). 1. Students identified by teachers as having learning difficulties. 2. Students who have been diagnosed with Asthma. 3. Students who participate steadily in physical activities prior to this research as shown by the physical activity questionnaire. 4. Students who have been treated for a psychiatric condition before as shown by the socio-demographic questionnaire. 5. Students who have physical disability such as will limit their participation in the program. 6. Students with severe depressive symptoms. Adolescent: 13 Year-18 Year 12 Year(s) 17 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 05/03/2020 Ondo State Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
State Secretariat, Alagbaka, Akure Ondo State. Akure 340271 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The objectives of this trial are as follows: 1. To assess the prevalence of depressive symptoms among in-school adolescents in Akure-South Local Government, Ondo State Pre-recruitment phase.
Primary Outcome To determine the effects of scheduled physical activities as a behavioral therapy for depressive symptoms among in-school adolescents. At the end of the intervention programme.
Secondary Outcome To determine the relationship between physical activity and self -esteem At the end of the intervention programme
Secondary Outcome To explore factors that influence adolescents' participation in physical activities. At the recruitment phase of the programme
Secondary Outcome To compare depressive symptoms between males and females in the intervention group pre and post intervention. At the end of the intervention programme
Secondary Outcome To explore if there will be a significant level of satisfaction in the intervention programme among the intervention group post intervention At the end of the intervention programme
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Akure secondary commercial high school Commercial, off Oke-Aro Akure Nigeria
Adu memorial high school. Green Park off Oke-Aro Akure Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Temitope Mary Olaoye No. 5b, Surulere Street Akure 340271 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mr James O. Olaoye No. 5b, Surulere quarters, Oke - Aro Akure Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Temitope Olaoye temitopeolaoye33@gmail.com +2348034107922 No. 5B, Surulere Street.
City Postal code Country Position/Affiliation
Akure Nigeria Student
Role Name Email Phone Street address
Scientific Enquiries Yetunde Adeniyi pcyetty@yahoo.com +2348035604963 University College Hospital
City Postal code Country Position/Affiliation
Ibadan Nigeria Consultant psychiatrist
Role Name Email Phone Street address
Public Enquiries Olakunle Omojola ccamhunibadan@yahoo.com +2349024459127 University of Ibadan
City Postal code Country Position/Affiliation
Ibadan Nigeria Administrator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes 1. The basic criteria for the study . E.g. Age, absence of physical and other mental health challenges. 2, Participant's score on the Rosenberg self-esteem scale. 3. Level of participant's involvement in programmed physical activity prior to the programme 4. Participant's attendance and compliance during the programme. Analytic Code,Informed Consent Form,Statistical Analysis Plan,Study Protocol 6-12 months after the programme Open access
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information